Intra-articular injections of hyaluronan act as lubricants to restore elasticity and viscosity to the arthritic knee. The procedure involves an arthrocentesis to aspirate the damaged synovial fluid from the knee. Then, to replace the fluid, the hyaluronan preparation is injected.

The following FDA approved hyaluronan preparations are the preferred injections:

Euflexxa® (1% sodium hyaluronate), Durolane® (hyaluronic acid), Supartz™ (sodium hyaluronate), and GelSyn-3™ (hyaluronic acid)
Intra-articular hyaluronan injections may be considered medically necessary when ALL of the following are met:

• The patient has documentation of diagnosis of symptomatic painful osteoarthritis of the knee and there is no evidence of inflammatory arthritis (e.g., rheumatoid arthritis); and
• There is documentation of failure to respond adequately to at least three (3) months of conservative* therapy; and
• There are no contraindications to the hyaluronan injections; and
• There is documentation that the pain interferes with functional activities (e.g., ambulation, prolonged standing); and
• Cause of pain cannot be attributed to other forms of joint disease; and
• The injections are performed by a licensed medical professional (e.g., MD, DO, PA or CRNP). Injections cannot be performed by nursing or other medical personnel.

*Conservative therapy includes the following:

• Activity modification, participation in a home exercise program implemented by a physical therapist, protective weight bearing; and
• Non-narcotic analgesics (e.g., acetaminophen, NSAIDS) 1 gram up to four (4) times daily, topical anti-inflammatory preparations including capsaicin cream applied to affected knee joint, and
• Intra-articular corticosteroid injections; or                                            
• The individual is unable to tolerate conservative therapy because of adverse side effects or other medical condition.

Arthrocentesis and the injection of hyaluronic acid derivatives for all other body joints is considered not medically necessary.

FDA approved Non-Preferred Injections (Hyalgan® (sodium hyaluronate), Orthovisc® (high molecular weight hyaluronan), Gel One® (cross-linked hyaluronate), Monovisc® (lightly cross-linked high molecular weight hyaluronic acid), GenVisc 850® (sodium hyaluronate), Synvisc® (hylan G-F 20), Synvisc-One® (hylan G-F 20), and Hymovis® (high molecular weight viscoelastic hyaluronan))
Non-preferred Intra-articular hyaluronan injections may be considered medically necessary when BOTH of the following are met:

• The member has met ALL the clinical criteria requirements as stated above for the preferred injections; and
• The member must have had an adequate* therapeutic trial and experienced a documented drug therapy failure** with all applicable preferred intra-articular hyaluronan products.

*An adequate therapeutic trial consists of using a preferred product at recommended doses for a period of time adequate to assess therapeutic benefit (unless the patient experiences an intolerable adverse effect due to drug therapy within that time period).  

**Drug therapy failure consists of not achieving the desired therapeutic goal, development of an intolerable adverse effect due to drug therapy, or development of a hypersensitivity reaction to the drug product. The length of therapy with the preferred product(s) and the reason(s) for drug therapy failure should be documented.

Non-Preferred Injections (Hyalgan® (sodium hyaluronate), Orthovisc® (high molecular weight hyaluronan, Gel One® (cross-linked hyaluronate), Hymovis® (high molecular weight viscoelastic hyaluronan), GenVisc 850® (sodium hyaluronate), Synvisc® (hylan G-F 20), Synvisc-One® (hylan G-F 20), and Monovisc® (lightly cross-linked high molecular weight hyaluronic acid)) are considered not medically necessary if the above criteria is not met.

Repeat Treatment Cycles
An additional course of the previously approved viscosupplementation therapy may be considered medically necessary for treatment of painful osteoarthritis of the knee when ALL of the following are met:

• At least six (6) months must have elapsed since the previous injection or completion of  the prior series of injections; and
• The patient and provider have elected to continue conservative/non-surgical management of the osteoarthritis (no surgery planned within six (6) months of viscosupplementation therapy); and
• The medical record must objectively document significant improvement in pain and functional capacity of the knee joint. (e.g., an improvement in an objective measurement of pain and/or functional status Visual Analog Scale [VAS], Western Ontario and McMaster Universities Osteoarthritis [WOMAC] Index, or other validated objective measure).

Repeat treatment cycles of Intra-Articular Hyaluronan injections are considered not medically necessary if the above criteria are not met.

Imaging guidance is considered not medically necessary when performed during intra-articular hyaluronan injections for osteoarthritis of the knee.

The following hyaluronan products are FDA-approved for intra-articular injections of the knee: 

• Euflexxa®  (1% sodium hyaluronate)
• Durolane® (hyaluronic acid)
• GelSyn-3™ (hyaluronic acid)
• Supartz®   (sodium hyaluronate)
• Hyalgan®  (sodium hyaluronate)
• Synvisc®   (hylan G-F 20)
• Synvisc-One™(hylan G-F 20)
• Orthovisc® (high-molecular-weight hyaluronan)
• Gel-One®  (hyaluronic acid)
• Monovisc® (lightly cross-linked high molecular weight hyaluronic acid)
• GenVisc 850® (sodium hyaluronate)
• Hymovis® (high molecular weight viscoelastic hyaluronan)

Dosage recommendations per the FDA label.